Food, drugs, devices › Philips Electronics North America Corporation
Device recall: Philips Network Firewall (Cisco ASA 5506), Model # 867098
FDA enforcement event 78849 is a device recall by Philips Electronics North America Corporation of Andover, MA, initiated 5 Oct 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 1 Jul 2019. Initiation: voluntary: firm initiated. Philips Electronics North America Corporation has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Electronics North America Corporation, Andover, MA.
Reason for recall
"Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information Center iX. The defect involves the clock signal component within the firewall. This component has a high probability of failing in appliances that have been running for greater than 18 months. If the clock signal…"
Distribution
"US Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0850-2018 | Philips Network Firewall (Cisco ASA 5506), Model # 867098 | 332 units | Class II | Terminated | 14 Mar 2018 |
Context
Other enforcement events for Philips Electronics North America Corporation
All 61 events for Philips Electronics North America Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information Center iX. The defect involves the clock signal component within the firewall. This component has a high probability of failing in appliances that have been running for greater than 18 months. If the clock signal…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Jul 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.